Over the past years I have not spoken in any great detail about guidance documents on computer validation for chromatographic systems and chromatography data systems (CDS) but concentrated on a specific topic from the regulations themselves. This is because most guidance has concentrated largely on computerized manufacturing and corporate systems, rather than laboratory systems.
This has changed now with the publication of the Good Automated Manufacturing Practice (GAMP) Forum's Good Practice Guide (GPG) on Validation of Laboratory Computerized Systems.1 However, this publication needs to be compared and contrasted with the AAPS publication on Qualification of Analytical Instruments (AIQ).2 Both publications have been written by a combination of representatives from the pharmaceutical industry, regulators, equipment vendors and consultants.
This will be a two-part discussion of the guide and where we should go to cover adequately both equipment qualification and validation of chromatography-based laboratory systems.Overview of the Guide
Published in 2005, the stated aim of the GPG is to develop a rational approach for computerized system validation in the laboratory and provide guidance for strategic and tactical issues in the area. Section 5 of the GPG also notes that "...the focus should be on the risk to data integrity and the risk to business continuity. The Guide assumes that these two factors are of equal importance."1
The GPG notes that companies need to establish their own policies and procedures based on their own risk management approaches. Of interest, the inside page of the GPG states that if companies manage their laboratory systems with the principles in the guide there is no guarantee that they will pass an inspection — therefore caveat emptor!
One major criticism is that the nine references cited in Appendix 5 are very selective and, therefore, the GPG ignores some key publications in this area such as:
Ignoring these papers biases the approach that this guide has taken and is a fatal flaw as we shall discuss later in this article.
Overall, the problem with this GPG is that you have to cherry pick the good bits from the bad. As with any performance appraisal system, let's start with the good news first and work our way downhill afterwards.